Device recall
Z-2302-2016: VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874…
FDA device recall · Class II · ORTHO-CLINICAL DIAGNOSTICS
Key facts
| Recall number (Z-number) | Z-2302-2016 |
|---|---|
| Recall event | 74366 |
| Product | VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using… |
| Product code | KLI |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 8, 2018 |
| 510(k) numbers | K964721 |
| FEI number | 3007111389 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database